ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Improving Efficacy and Safety of TB and HIV Treatment by Nutritional Supplementation in Mwanza, Tanzania: A prospective, randomised, open labelled study

Acronym

TB-PK study

Study hypothesis

A defined, high energy, vitamin and mineral containing nutritional supplement to undernourished tuberculosis (TB) patients during the first two months of intensive treatment will improve drug absorption, ameliorate adverse effects and fasten recovery of lean body mass.

Ethics approval

The local medical ethics committee approved on the 1st of June 2010 (ref: NIMR/HQ/R.8a/Vol.IX/953)

Study design

Prospective open labelled randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Is prepared in English and in local language. Will in addition be orally presented to participants by study nurses.

Condition

Tuberculosis with and without HIV co-infection

Intervention

Patients will be randomised to either:1. Intervention group:Five high energy biscuits containing 1000 kcal plus vitamins, minerals zinc and selenium every day during the intensive phase of the anti TB treatment as part of the Directly Observed Treatment (DOT) regimen.2. Control group: Standard care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Increase in TB drug exposure (AUC) during the first two months in the group receiving intervention compared to the group receiving standard care.